FDA Inspection
Hemagen Diagnostics IncHemagen Diagnostics Inc – FDA Inspection, Jan 10, 2018
Record Details
This FDA Inspection record concerns Hemagen Diagnostics Inc, with an inspection on January 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9a37d426-9ef2-4c1c-b2bf-43581dce2e7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037233
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Hemagen Diagnostics Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hemagen Diagnostics Inc
- FDA Inspection 1317040 - 2026-05-14
- FDA Inspection 1208393 - 2023-06-14
- FDA Inspection 918077 - 2015-03-10
- FDA Inspection 812190 - 2012-12-20
- FDA Inspection 677299 - 2010-08-25
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